U2 Total Knee System

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name: U2 Total Knee System FDA UDI
Generic Name: Knee femur prosthesis trial, reusable FDA UDI
Device Name: Femoral trial, PS, #1.5, right FDA UDI
Model / Reference: 2103-4215 FDA UDI
Description: Femoral trial, PS, #1.5, right FDA UDI

Identifiers

Catalog Number: 2103-4215 FDA UDI
Primary DI / UDI-DI: 04719872162681 FDA UDI
510(k) Number: K120507 FDA UDI
K131116 FDA UDI
K131864 FDA UDI
K132752 FDA UDI
K140073 FDA UDI
K140075 FDA UDI
K150829 FDA UDI
K150832 FDA UDI
K152430 FDA UDI
K161360 FDA UDI
K161705 FDA UDI
FDA Product Code: MBH FDA UDI
OIY FDA UDI
JWH FDA UDI
GMDN Term: Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 FDA UDI
888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Knee femur prosthesis trial, reusable

U2 Total Knee System by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee femur prosthesis trial, reusable.

Lospa Modular Knee System — Corentec Co., Ltd · Class II
OSS™ — Biomet Orthopedics, Inc. · Class II
VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
Natural-Knee® — Zimmer, Inc. · Class II
NexGen® — Zimmer, Inc. · Class II
LOSPA Knee System — Corentec Co., Ltd · Class II
Persona® — Zimmer, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: United Orthopedic Corp.

Sources (1)

FDA UDI c7dd0aef-e57c-4684-8923-783d86b813b1 37 fields · synced Jun 1, 2026